MESA Rail™ AIS Study - Preservation of Curve Correction

• Sponsor: K2M, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02062606
• Collaborator: (none)
• Enrollment: 188
• Duration (Months): 69.8

Study Details

Study Description

Brief Summary

To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve correction demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as compared to literature reported outcomes for standard Cobalt Chrome (CoCr) rod systems in the treatment of Adolescent Idiopathic Scoliosis (AIS).

Condition or Disease	Intervention/Treatment	Phase
Adolescent Idiopathic Scoliosis	Device: MESA Rail™ Deformity System

Detailed Description

Patients treated with the Ø5.5mm or Ø4.5mm MESA Rail™ Deformity System that had:

Diagnosis of AIS requiring surgical treatment for selective non-cervical fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies.

AIS cases must be classified as a Lenke type 1 or type 2 curve (lumbar modifiers and thoracic sagittal profiles will be noted but not restrictive).

Age at time of surgery of ≥ 11 years old and ≤ 21 years old.

Study Design

• Study Type: Observational
• Actual Enrollment: 188 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Preservation of Thoracic Kyphosis and Coronal Curve Correction as a Function of Rod Stiffness in the Surgical Treatment of Adolescent Idiopathic Scoliosis (AIS) With the Use of the K2M MESA Rail™ Deformity System
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Feb 23, 2020
• Actual Study Completion Date: Feb 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
AIS Surgical implantation of the K2M MESA Rail™ Deformity System in the treatment of Adolescent Idiopathic Scoliosis (AIS).	Device: MESA Rail™ Deformity System; MESA Rail™ (cross-sectioned rod) with MESA pedicle screws compared to traditional rod use in the literature

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months [Baseline (up to 90 days before surgery), 24 months]

   Restoration and maintenance of thoracic kyphosis and coronal curve correction. Thoracic kyphosis (Coronal Curve): measurement of curvature from the upper endplate of T4 to the lower endplate of T12.

2. Number of Participants With Adverse Events [Up to 24 months]

   Number of participants with SAE and AE for the various intervals

Secondary Outcome Measures

1. Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months [Baseline (up to 90 days before surgery), 24 months]

   Evaluation of the improvement of the Back VAS and Hip/Leg VAS (assessed together) at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness /tingling and the location of symptoms were captured and evaluated. VAS scale ranged from 0 - 100mm with the 100mm accounting for the highest level of pain.

2. Change From Baseline in Quality of Life Scores on the SRS-22r at 24 Months [Baseline (up to 90 days before surgery), 24 months]

   The Revised Scoliosis Research Society-22 (SRS-22r) is a specific questionnaire for spine conditions. It is applied to patients with idiopathic scoliosis, whose conditions and treatments have a great impact on their quality of life. The SRS 22r was created and revised with the purpose of evaluating this impact from the patient's point of view. The reviewed version contains 22 questions distributed into five domains: function/activity (FA), pain (P), self- image/appearance (SA), mental health (MH) and satisfaction with treatment (ST). The scores vary from 1 to 5 in which 5 is the best health quality of life of patients.

3. Patient Satisfaction [12 months and 24 months]

   At the 12 month and 24 month follow-up visits, subjects were asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No).

4. Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria [24 months]

   At the 24 month follow-up visit, the Investigator rated the clinical disposition of each study subject according to Odom's Criteria as follows: Excellent: all pre-operative symptoms relieved, able to carry out daily occupations without impairment. Good: minimum persistence of pre-operative symptoms, able to carry out daily occupations without significant interference. Fair/Satisfactory: relief of some pre-operative symptoms but physical activity is significantly limited. Poor: symptoms or signs unchanged or worsened.

5. Length of Surgery Time [During surgery]

   The length of the surgical procedure from the initial incision to final closure were captured.

6. Length of Anesthesia Time [During surgery]

   The length of time the patient is under anesthesia was captured.

7. Estimated Blood Loss [During surgery]

   The amount of blood loss over the entire length of the surgery was captured.

8. Length of Hospital Stay [Admission to Discharge]

   The length of the hospital stay from the date of admission to the date of discharge.

9. Change in Percentage of Participants Able to Return to Work/School [Pre-Op to 24 months]

   The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the change in percentage of participants who were able to return to work without any restrictions

10. Use of Narcotics Post-surgery [Pre-Op to 24 months]

    The types and dosages of any narcotics taken by the patient pre- and post-surgery was documented.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of AIS requiring surgical treatment for selective thoracic/lumbar fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies. AIS cases must be classified as a Lenke type 1 or type 2 curve. No cervical vertebrae are to be incorporated into the construct.

• Willingness and ability to comply with the requirements of the protocol including follow-up requirements.

• Willing and able to sign a study specific informed consent form or, in the case of a patient who is a minor, provide assent and the minor patient's parent/legal guardian provides written consent to participate.

• Age range of ≥ 11 years old and ≤ 21 years old at time of surgery.

Exclusion Criteria:

• Previous anterior or posterior spine surgery at the index levels.

• Previous posterior spine surgery (e.g., posterior element decompression) that destabilizes the cervical/thoracic/lumbar spine.

• Active systemic infection or infection at the operative site.

• Co-morbid medical conditions of the spine or upper/lower extremities that may affect the thoracic or lumbar spine neurological and/or pain assessment.

• Metabolic bone disease such as osteoporosis that contradicts spinal surgery.

• History of an osteoporotic fracture.

• History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism.

• Taking medications that may interfere with bony/soft tissue healing including chronic steroid use.

• Known allergy to titanium or cobalt chrome.

• Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia.

• Insulin-dependent type 1 or type 2 diabetes.

• Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion.

• Pregnant, or intend to become pregnant, during the course of the study.

• Severe obesity (Body Mass Index > 40).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• K2M, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 21, 2014

More Information

Publications

• Kim YJ, Lenke LG, Bridwell KH, Kim J, Cho SK, Cheh G, Yoon J. Proximal junctional kyphosis in adolescent idiopathic scoliosis after 3 different types of posterior segmental spinal instrumentation and fusions: incidence and risk factor analysis of 410 cases. Spine (Phila Pa 1976). 2007 Nov 15;32(24):2731-8.
• Newton PO, Yaszay B, Upasani VV, Pawelek JB, Bastrom TP, Lenke LG, Lowe T, Crawford A, Betz R, Lonner B; Harms Study Group. Preservation of thoracic kyphosis is critical to maintain lumbar lordosis in the surgical treatment of adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2010 Jun 15;35(14):1365-70. doi: 10.1097/BRS.0b013e3181dccd63.
• Wattenbarger JM, Richards BS, Herring JA. A comparison of single-rod instrumentation with double-rod instrumentation in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2000 Jul 1;25(13):1680-8.

• Responsible Party: K2M, Inc.
• ClinicalTrials.gov Identifier: NCT02062606
• Other Study ID Numbers: CA-001
• First Posted: Feb 13, 2014
• Last Update Posted: Apr 12, 2021
• Last Verified: Apr 1, 2021

• Keywords provided by K2M, Inc.: Scoliosis; Spinal Curvatures; Spinal Diseases; Adolescent Idiopathic Scoliosis; Spinal Deformity
• Additional relevant MeSH terms: Scoliosis

Study Results

Participant Flow

Arm/Group Title	K2M MESA Rail™ Deformity System
Arm/Group Description	Patients treated with the Ø5.5mm or Ø4.5mm MESA Rail Deformity System that had: Diagnosis of AIS requiring surgical treatment for selective thoracic/lumbar fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies. AIS cases must be classified as a Lenke type 1 or type 2 curve (lumbar modifiers and thoracic sagittal profiles were noted but not restrictive). An age at time of surgery of ≥ 11 years old and ≤ 21 years old
Period Title: Overall Study
STARTED	188
COMPLETED	99
NOT COMPLETED	89

Baseline Characteristics

Arm/Group Title	Demographics and Baseline Characteristics
Arm/Group Description	This is a demographic and baseline characteristics of the patient population. This includes parameters such as Age, Gender, Height, Weight Body Mass Index (BMI) and Tobacco Usage.
Overall Participants	188
Age (Count of Participants)
<=18 years	180 95.7%
Between 18 and 65 years	8 4.3%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.65 (2.16)
Sex: Female, Male (Count of Participants)
Female	139 73.9%
Male	49 26.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	170 90.4%
New Zealand	4 2.1%
Australia	14 7.4%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	160.4 (10.8)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	55.3 (13.53)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	21.43 (4.66)
Tobacco Use (Count of Participants)
Never	186 98.9%
Quit	1 0.5%
Currently Use	1 0.5%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months
Description	Restoration and maintenance of thoracic kyphosis and coronal curve correction. Thoracic kyphosis (Coronal Curve): measurement of curvature from the upper endplate of T4 to the lower endplate of T12.
Time Frame	Baseline (up to 90 days before surgery), 24 months

Outcome Measure Data

Analysis Population Description

98 of the 99 participants who returned at 24 Months had the thoracic kyphosis measurement.

Arm/Group Title	All Patients
Arm/Group Description	The overall change of Thoracic Kyphosis (TK) within the current study.
Measure Participants	98
Mean (95% Confidence Interval) [degrees]	-3.84

2. Primary Outcome

Title	Number of Participants With Adverse Events
Description	Number of participants with SAE and AE for the various intervals
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

This is an analysis of the number of participants that reported any form of adverse event. Overall participants with any AE or SAE. 5 of the 17 SAE participants did not experience a non-SAE events. The other 12 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed.

Arm/Group Title	Up to Post-Operative	Post-Operative to 3 Months	3 to 6 Months	6 to 12 Months	12 to 24+ Months	Overall
Arm/Group Description	participants with SAE and AE	participants with SAE and AE	participants with SAE and AE	participants with SAE and AE	participants with SAE and AE	Overall number of participants with SAE and AEs
Measure Participants	188	160	147	135	99	188
Any AE	62 33%	7 NaN	21 NaN	25 NaN	36 NaN	98 NaN
Any AE : Procedure Related	44 23.4%	0 NaN	12 NaN	9 NaN	18 NaN	67 NaN
Any AE : Device Related	16 8.5%	0 NaN	3 NaN	6 NaN	7 NaN	26 NaN
Any AE : Mild	44 23.4%	6 NaN	17 NaN	20 NaN	29 NaN	79 NaN
Any AE : Moderate	19 10.1%	1 NaN	4 NaN	5 NaN	10 NaN	31 NaN
Any AE : Severe	5 2.7%	1 NaN	0 NaN	1 NaN	0 NaN	7 NaN
Any SAE	10 5.3%	1 NaN	0 NaN	4 NaN	3 NaN	17 NaN
Any SAE : Procedure Related	8 4.3%	0 NaN	0 NaN	1 NaN	2 NaN	11 NaN
Any SAE : Device Related	2 1.1%	0 NaN	0 NaN	1 NaN	2 NaN	5 NaN
Any SAE : Mild	3 1.6%	0 NaN	0 NaN	1 NaN	1 NaN	5 NaN
Any SAE : Moderate	4 2.1%	0 NaN	0 NaN	2 NaN	2 NaN	7 NaN
Any SAE : Severe	4 2.1%	1 NaN	0 NaN	1 NaN	0 NaN	6 NaN

3. Secondary Outcome

Title	Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months
Description	Evaluation of the improvement of the Back VAS and Hip/Leg VAS (assessed together) at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness /tingling and the location of symptoms were captured and evaluated. VAS scale ranged from 0 - 100mm with the 100mm accounting for the highest level of pain.
Time Frame	Baseline (up to 90 days before surgery), 24 months

Outcome Measure Data

Analysis Population Description

13 out of the 99 participants who returned at 24 months, did not complete the survey.

Arm/Group Title	Back	Left Leg/Hip	Right Leg/Hip
Arm/Group Description	pain scores on the VAS	pain scores on the VAS	pain scores on the VAS
Measure Participants	86	86	86
Mean (Standard Deviation) [score on a scale]	-16.9 (29.5)	-0.2 (13.2)	-2 (17.8)

4. Secondary Outcome

Title	Change From Baseline in Quality of Life Scores on the SRS-22r at 24 Months
Description	The Revised Scoliosis Research Society-22 (SRS-22r) is a specific questionnaire for spine conditions. It is applied to patients with idiopathic scoliosis, whose conditions and treatments have a great impact on their quality of life. The SRS 22r was created and revised with the purpose of evaluating this impact from the patient's point of view. The reviewed version contains 22 questions distributed into five domains: function/activity (FA), pain (P), self- image/appearance (SA), mental health (MH) and satisfaction with treatment (ST). The scores vary from 1 to 5 in which 5 is the best health quality of life of patients.
Time Frame	Baseline (up to 90 days before surgery), 24 months

Outcome Measure Data

Analysis Population Description

While 99 participants completed 24 month interval, 14 patients out of the 99 did not did not complete the survey.

Arm/Group Title	24 Month
Arm/Group Description	Baseline in quality of life scores on the SRS-22r
Measure Participants	85
Mean (Standard Deviation) [score on a scale]	0.6 (0.7)

5. Secondary Outcome

Title	Patient Satisfaction
Description	At the 12 month and 24 month follow-up visits, subjects were asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No).
Time Frame	12 months and 24 months

Outcome Measure Data

Analysis Population Description

Patient self-assessment of the procedure at 12M and 24M

Arm/Group Title	12 Month	24 Month
Arm/Group Description	Patient satisfaction at 12 Month	Patient satisfaction at 12 Month
Measure Participants	135	99
Yes	124 66%	86 NaN
No	4 2.1%	2 NaN
Not Reported	7 3.7%	11 NaN
Yes	105 55.9%	76 NaN
No	23 12.2%	12 NaN
Not Reported	7 3.7%	11 NaN

6. Secondary Outcome

Title	Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria
Description	At the 24 month follow-up visit, the Investigator rated the clinical disposition of each study subject according to Odom's Criteria as follows: Excellent: all pre-operative symptoms relieved, able to carry out daily occupations without impairment. Good: minimum persistence of pre-operative symptoms, able to carry out daily occupations without significant interference. Fair/Satisfactory: relief of some pre-operative symptoms but physical activity is significantly limited. Poor: symptoms or signs unchanged or worsened.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Patients who were rated based on the outcome of their treatment and would indicate either Excellent, Good or Fair/Satisfactory. No responses are shown under missing

Arm/Group Title	Investigator's Rating
Arm/Group Description	Investigator's rating of subject's clinical disposition using Odom's Criteria
Measure Participants	99
Fair/Satisfactory	2 1.1%
Good	15 8%
Excellent	78 41.5%
Missing	4 2.1%

7. Secondary Outcome

Title	Length of Surgery Time
Description	The length of the surgical procedure from the initial incision to final closure were captured.
Time Frame	During surgery

Outcome Measure Data

Analysis Population Description

186 patients had their surgery times recorded. There were 3 additional procedures staged increasing the overall number of units analyzed to 189.

Arm/Group Title	Length of Surgery Time
Arm/Group Description	The length of the surgical procedure from the initial incision to final closure
Measure Participants	186
Measure surgeries	189
Mean (Standard Deviation) [Minutes]	267.01 (79.89)

8. Secondary Outcome

Title	Length of Anesthesia Time
Description	The length of time the patient is under anesthesia was captured.
Time Frame	During surgery

Outcome Measure Data

Analysis Population Description

183 subjects had anesthesia time included. There were 3 staged procedures increasing the overall number of units analyzed to 186.

Arm/Group Title	Length of Anesthesia Time
Arm/Group Description	The length of time the patient is under anesthesia was captured.
Measure Participants	183
Measure surgeries	186
Mean (Standard Deviation) [Minutes]	373.67 (91.97)

9. Secondary Outcome

Title	Estimated Blood Loss
Description	The amount of blood loss over the entire length of the surgery was captured.
Time Frame	During surgery

Outcome Measure Data

Analysis Population Description

187 patients had blood loss included. There were 3 additional procedures staged increasing the overall number of units analyzed to 190.

Arm/Group Title	Estimated Blood Loss
Arm/Group Description	The amount of blood loss over the entire length of the surgery was captured.
Measure Participants	187
Measure surgeries	190
Mean (Standard Deviation) [Cubic Centimeters]	672.34 (588.14)

10. Secondary Outcome

Title	Length of Hospital Stay
Description	The length of the hospital stay from the date of admission to the date of discharge.
Time Frame	Admission to Discharge

Outcome Measure Data

Analysis Population Description

186 patients completed admit and discharge dates

Arm/Group Title	Length of Hospital Stay
Arm/Group Description	The length of the hospital stay from the date of admission to the date of discharge
Measure Participants	186
Measure surgeries	186
Mean (Standard Deviation) [Days]	5.28 (1.79)

11. Secondary Outcome

Title	Change in Percentage of Participants Able to Return to Work/School
Description	The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the change in percentage of participants who were able to return to work without any restrictions
Time Frame	Pre-Op to 24 months

Outcome Measure Data

Analysis Population Description

Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row.

Arm/Group Title	Pre-Op	Initial Post Op	3 Month	6 Month	12 Month	24 Month
Arm/Group Description	The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.	The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.	The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.	The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.	The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.	The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.
Measure Participants	188	181	160	147	135	99
Unemployed, unrelated to back/leg conditions	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Not attending work/school by choice	11 5.9%	22 NaN	7 NaN	2 NaN	3 NaN	0 NaN
Unable to go due to back/leg pain/conditions	0 0%	57 NaN	4 NaN	0 NaN	0 NaN	0 NaN
Attending work/school with some restrictions	5 2.7%	83 NaN	104 NaN	44 NaN	14 NaN	4 NaN
Attending work/school with no restrictions	172 91.5%	19 NaN	44 NaN	101 NaN	117 NaN	93 NaN
Missing	0 0%	0 NaN	1 NaN	0 NaN	1 NaN	2 NaN

12. Secondary Outcome

Title	Use of Narcotics Post-surgery
Description	The types and dosages of any narcotics taken by the patient pre- and post-surgery was documented.
Time Frame	Pre-Op to 24 months

Outcome Measure Data

Analysis Population Description

Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row.

Arm/Group Title	Pre-Op	Initial Post Op	3 Month	6 Month	12 Month	24 Month
Arm/Group Description	The types and dosages of any narcotics taken by the patient pre- and post-surgery was be documented.	The types and dosages of any narcotics taken by the patient pre- and post-surgery was be documented.	The types and dosages of any narcotics taken by the patient pre- and post-surgery was be documented.	The types and dosages of any narcotics taken by the patient pre- and post-surgery was be documented.	The types and dosages of any narcotics taken by the patient pre- and post-surgery was be documented.	The types and dosages of any narcotics taken by the patient pre- and post-surgery was be documented.
Measure Participants	188	181	160	147	135	99
None	128 68.1%	46 NaN	118 NaN	114 NaN	112 NaN	78 NaN
Non-narcotics or NSAIDS	53 28.2%	28 NaN	29 NaN	28 NaN	22 NaN	16 NaN
Intermittent short-acting narcotics	6 3.2%	77 NaN	9 NaN	5 NaN	1 NaN	1 NaN
Chronic daily short-acting narcotics	1 0.5%	18 NaN	2 NaN	0 NaN	0 NaN	0 NaN
Chronic daily long-acting narcotics	0 0%	6 NaN	1 NaN	0 NaN	0 NaN	0 NaN
IV or injected narcotics	0 0%	6 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Epidural/Facet injection	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Missing	0 0%	0 NaN	1 NaN	0 NaN	0 NaN	4 NaN
None	157 83.5%	151 NaN	141 NaN	125 NaN	118 NaN	84 NaN
Non-narcotics or NSAIDS	31 16.5%	22 NaN	18 NaN	22 NaN	17 NaN	13 NaN
Intermittent short-acting narcotics	0 0%	7 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Chronic daily short-acting narcotics	0 0%	1 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Chronic daily long-acting narcotics	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
IV or injected narcotics	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Epidural/Facet injection	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Missing	0 0%	0 NaN	1 NaN	0 NaN	0 NaN	2 NaN

Adverse Events

Time Frame	From Operative to 24+ Months
Adverse Event Reporting Description	Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
Arm/Group Title	Participants With Adverse Events
Arm/Group Description	Overall participants with any AE or SAE. 5 of the 17 SAE participants did not experience a non-SAE events. The other 12 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed.
All Cause Mortality
	Participants With Adverse Events
	Affected / at Risk (%)	# Events
Total	0/188 (0%)
Serious Adverse Events
	Participants With Adverse Events
	Affected / at Risk (%)	# Events
Total	17/188 (9%)
Blood and lymphatic system disorders
Infectious mononucleosis	1/188 (0.5%)	1
Sickle cell anaemia with crisis	1/188 (0.5%)	1
Gastrointestinal disorders
Abdominal Pain	1/188 (0.5%)	1
Abdominal pain upper	1/188 (0.5%)	1
Nausea	1/188 (0.5%)	1
Vomiting	2/188 (1.1%)	2
General disorders
Complications associated with device	1/188 (0.5%)	1
Cyst	1/188 (0.5%)	1
Discomfort	1/188 (0.5%)	1
Hepatobiliary disorders
Cholecystitis	1/188 (0.5%)	1
Infections and infestations
Infection	1/188 (0.5%)	1
Pneumonia	1/188 (0.5%)	1
Wound infection	1/188 (0.5%)	1
Injury, poisoning and procedural complications
Wound dehiscence	1/188 (0.5%)	1
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome	1/188 (0.5%)	1
Nervous system disorders
Headache	1/188 (0.5%)	1
Motor dysfunction	3/188 (1.6%)	3
Sensory loss	1/188 (0.5%)	1
Product Issues
Device failure	1/188 (0.5%)	1
Psychiatric disorders
Anxiety	1/188 (0.5%)	1
Depression	1/188 (0.5%)	2
Respiratory, thoracic and mediastinal disorders
Atelectasis	1/188 (0.5%)	1
Surgical and medical procedures
Medical device removal	1/188 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Participants With Adverse Events
	Affected / at Risk (%)	# Events
Total	93/188 (49.5%)
Blood and lymphatic system disorders
Anaemia	6/188 (3.2%)	6
Infectious mononucleosis	1/188 (0.5%)	2
Splenomegaly	1/188 (0.5%)	1
Cardiac disorders
Cardiac disorder	2/188 (1.1%)	2
Tachycardia	1/188 (0.5%)	1
Eye disorders
Conjunctivitis	1/188 (0.5%)	1
Gastrointestinal disorders
Abdominal discomfort	1/188 (0.5%)	1
Abdominal pain	3/188 (1.6%)	3
Abdominal pain upper	1/188 (0.5%)	1
Constipation	2/188 (1.1%)	2
Diarrhoea	1/188 (0.5%)	1
Functional gastrointestinal disorder	3/188 (1.6%)	3
Nausea	4/188 (2.1%)	4
Salivary gland mucocoele	1/188 (0.5%)	1
Vomiting	4/188 (2.1%)	4
General disorders
Chest pain	10/188 (5.3%)	11
Chills	1/188 (0.5%)	1
Complication associated with device	4/188 (2.1%)	5
Cyst	2/188 (1.1%)	2
Flank pain	2/188 (1.1%)	2
Hypertrophy	1/188 (0.5%)	1
Pain	16/188 (8.5%)	20
Pyrexia	4/188 (2.1%)	4
Respiratory complication associated with device	1/188 (0.5%)	1
Swelling	1/188 (0.5%)	1
Immune system disorders
Drug hypersensitivity	1/188 (0.5%)	1
Infections and infestations
Abscess	1/188 (0.5%)	1
Infection	4/188 (2.1%)	4
Influenza	2/188 (1.1%)	2
Otitis externa	1/188 (0.5%)	1
Otitis media	2/188 (1.1%)	2
Pharyngitis streptococcal	1/188 (0.5%)	2
Viral pharyngitis	2/188 (1.1%)	2
Wound infection	3/188 (1.6%)	3
Injury, poisoning and procedural complications
Fall	7/188 (3.7%)	12
Incision site discharge	1/188 (0.5%)	1
Joint injury	2/188 (1.1%)	2
Limb injury	1/188 (0.5%)	1
Post procedural complication	1/188 (0.5%)	1
Road traffic accident	4/188 (2.1%)	4
Suture related complication	1/188 (0.5%)	1
Wound	2/188 (1.1%)	3
Wound dehiscence	1/188 (0.5%)	1
Investigations
Blood calcium decreased	1/188 (0.5%)	1
Body temperature decreased	1/188 (0.5%)	1
Weight decreased	1/188 (0.5%)	1
Metabolism and nutrition disorders
Dehydration	1/188 (0.5%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	8/188 (4.3%)	15
Back pain	24/188 (12.8%)	30
Muscle spasm	1/188 (0.5%)	1
Muscular weakness	1/188 (0.5%)	2
Musculoskeletal chest pain	2/188 (1.1%)	2
Musculoskeletal apin	15/188 (8%)	18
Musculoskeletal stiffness	1/188 (0.5%)	1
Myalgia	2/188 (1.1%)	2
Neck pain	5/188 (2.7%)	5
Pain in extremity	3/188 (1.6%)	5
Patellofemoral pain syndrome	1/188 (0.5%)	1
Pelvic deformity	1/188 (0.5%)	1
Pseudarthrosis	1/188 (0.5%)	1
Spinal disorder	1/188 (0.5%)	1
Temporomandibular joint syndrome	1/188 (0.5%)	1
Dysaesthesia	1/188 (0.5%)	1
Headache	3/188 (1.6%)	4
Migraine	1/188 (0.5%)	1
Nervous system disorders
Carpal tunnel syndrome	1/188 (0.5%)	1
Dizziness	1/188 (0.5%)	1
Hypoaesthesia	8/188 (4.3%)	9
Motor dysfunction	3/188 (1.6%)	4
Neuralgia	2/188 (1.1%)	3
Paraesthesia	2/188 (1.1%)	3
Poor quality sleep	1/188 (0.5%)	1
Spinal muscular atrophy	1/188 (0.5%)	1
Syncope	3/188 (1.6%)	3
Vertigo	1/188 (0.5%)	1
Product Issues
Device failure	2/188 (1.1%)	2
Psychiatric disorders
Anxiety	2/188 (1.1%)	2
Attention deficit/hyperactivity disorder	1/188 (0.5%)	1
Renal and urinary disorders
Bladder dysfunction	2/188 (1.1%)	2
Respiratory, thoracic and mediastinal disorders
Atelectasis	1/188 (0.5%)	1
Dyspnoea	1/188 (0.5%)	1
Musculoskeletal chest pain	5/188 (2.7%)	5
Oropharyngeal pain	1/188 (0.5%)	1
Pleural effusion	2/188 (1.1%)	2
Pneumomediastinum	1/188 (0.5%)	1
Skin and subcutaneous tissue disorders
Body tinea	1/188 (0.5%)	1
Dermatitis contact	1/188 (0.5%)	1
Erythema	1/188 (0.5%)	1
Folliculitis	1/188 (0.5%)	1
Kerion	1/188 (0.5%)	1
Pruritus	3/188 (1.6%)	3
Rash	4/188 (2.1%)	4
Skin irritation	1/188 (0.5%)	1
Surgical and medical procedures
Incisional drainage	2/188 (1.1%)	2
Vascular disorders
Haematoma	2/188 (1.1%)	2
Hypotension	1/188 (0.5%)	1
Orthostatic hypotension	1/188 (0.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Institution/PI shall not disclose/use any confidential/proprietary information (CI) disclosed to/developed by the Institution during the study. Institution/PI agree to hold the results of the Study in confidence, and shall not disclose them except with prior written consent of K2M. Institution agrees to submit any Articles to K2M for review prior to publication and agrees to edit out any confidential information identified by K2M.